Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520878
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-20
Brief Title:
Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of NANO-PSO omega 5 Supplementation on Cognitive Abilities of Older Adults with Mild to Moderate Non-vascular Cognitive Impairment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COGMEG5
Brief Summary:
The objective of this randomized triple-blind placebo-controlled clinical trial is to compare NANO-PSO therapy against placebo in improving cognitive abilities in older adults with mild to moderate non-vascular cognitive impairment over six months of treatment The primary questions it aims to answer are
Does NANO-PSO therapy improve cognitive abilities in older adults with mild to moderate non-vascular cognitive impairment over six months of treatment compared to placebo
The researchers will compare NANO-PSO therapy against placebo to see if it benefits the cognitive abilities of geriatric patients
Participants will be required to
Consume two capsules of NANO-PSO or placebo daily in the morning for six months
Be evaluated monthly by phone to identify potential risks and ensure adherence to the treatment
Be evaluated in person at 90 and 180 days of treatment
The patient or primary caregiver must maintain a log to confirm daily dose consumption and will have a direct communication line with the attending physicians in case of questions about ingestion or possible adverse reactions
At the end of the final patient evaluation a quality questionnaire will be administered
Does NANO-PSO therapy improve cognitive abilities in older adults with mild to moderate non-vascular cognitive impairment over six months of treatment compared to placebo
The researchers will compare NANO-PSO therapy against placebo to see if it benefits the cognitive abilities of geriatric patients
Participants will be required to
Consume two capsules of NANO-PSO or placebo daily in the morning for six months
Be evaluated monthly by phone to identify potential risks and ensure adherence to the treatment
Be evaluated in person at 90 and 180 days of treatment
The patient or primary caregiver must maintain a log to confirm daily dose consumption and will have a direct communication line with the attending physicians in case of questions about ingestion or possible adverse reactions
At the end of the final patient evaluation a quality questionnaire will be administered
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None